Imaging-Guided Vessel Sizing in the Tibial Arteries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Standardized Technique for OCT Use in the Lower Limb
研究概览
简要总结
This study aims to investigate the utilization of intravascular imaging in treatment of tibial vessels in peripheral artery disease and critical limb ischemia (CLI). The primary goal is to compare optical coherence tomography (OCT) with traditional digital subtraction angiography (DSA) in determining best treatment strategy and vessel optimization, in an effort to improve long term patency and successful wound healing in CLI. Secondary comparison with intravascular ultrasound (IVUS) is undertaken when clinically feasible. The hypothesis is that the adjunctive use of intravascular imaging will affect vessel sizing and anticipated treatment modalities, and therein affect the long term primary patency rates.
详细描述
This is a prospective, nonrandomized trial to investigate the adjunctive use of intravascular imaging in tibial vessel interventions. The evaluation of OCT is primarily to: (a) establish feasibility and reproducibility in below-the-knee vessels, (b) determine the optimal protocol imaging to produce the optimal clear image frame and clear image length, (c) provide detailed lesion characteristics of tibial disease, (d) assess for luminal gain post-intervention. Operator-determined sizing will be compared against University Hospitals Core Imaging Laboratory assessment of OCT, IVUS (when applicable), and quantitative vessel analysis (QVA).
Subjects will follow up per routine care with corresponding ankle-brachial index and toe-brachial index at 1, 3, 6, and 12 months or as clinically indicated. Wound and amputation data will be collected at the pre-procedural visit and with each subsequent visit. Wound care will be managed by our wound care associates in podiatry, vascular medicine, vascular surgery, or plastic surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with presence of Rutherford IV-VI
- •Presence of ≥1 tibial artery involvement requiring endovascular treatment
排除标准
- •Patients who do not have tibial disease appropriate for intervention
- •Estimated glomerular filtration rate <30 mL/min not on hemodialysis
结局指标
主要结局
Standardized Technique for OCT Use in the Lower Limb
时间窗: 12 months
To develop a protocolized, reproducible technique to maximize the Clear Image Length (CIL) on 75 mm pullbacks using 100% contrast in the tibial arteries. The goal is to compare intravascular ultrasound (IVUS) and optical coherence tomography (OCT) with traditional digital subtraction angiography (DSA) in determining best treatment strategy and vessel optimization, in an effort to improve long term patency and successful wound healing in CLI. The hypothesis is that the adjunctive use of intravascular imaging will affect vessel sizing and anticipated treatment modalities, and therein affect the long term primary patency rates.
次要结局
- Vessel Characteristics: Minimal Lumen Area(12 months)
- Vessel Characteristics: Reference Vessel Diameter(12 months)
- Plaque Characteristics: Calcium Depth(12 months)
- Attenuation(12 months)
- Vessel Characteristics Following Intervention: Plaque Modification(12 months)
- Vessel Characteristics Following Intervention: Dissections(12 months)
- Comparison of Percent Contrast(12 months)
- Vessel Characteristics: Percentage Stenosis(12 months)
- Vessel Characteristics Following Intervention: Luminal Gain(12 months)
- Vessel Characteristics: Reference Vessel Area(12 months)
- Plaque Characteristics: Morphology(12 months)
- Plaque Characteristics: Calcium Arc(12 months)
- Plaque Characteristics: Fibrous cap(12 months)